Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography

NCT ID: NCT03523494

Last Updated: 2019-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-03-30

Brief Summary

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Development of lympho-proliferation reticulation quantification using CT.

Detailed Description

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It is known that fibrosis of the subcutaneous soft tissue progresses over time in the lymph edema, and this change progresses to reticulation pattern.

Authors will develop a digital subtraction technique for the extraction of lympho-proliferative reticulation using the Housfield unit of non-reticulation structure (bones, muscles, tendons, vessels, nerves) in the axial image of CT.

Based on the medical records, authors will develop an early diagnosing tool by checking the correlation of the values derived the new technique with circumference, multi-frequency bio-electric impedance analysis, ISO sub-stage, and lymphascintigraphy, and qualify the cut-off values showing high sensitivity and specificity through the receiver operating characteristics (ROC) curve analyses.

Conditions

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Lymphedema Secondary Lymphedema CT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Normal limb

Normal

No interventions assigned to this group

Abnormal limb

Lymph Edema

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs

Exclusion Criteria

* Primary lymph edema (congenital lymph edema, lymph edema precox, lymph edema tarda)
* Lymph edema simultaneously involving both limbs
* Patients who undertook implantation of electrical devices such as cardic pacemakers
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Ho Hwang

Associate professor, PhD and MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Ho Hwang, M.D., Ph.D.

Role: STUDY_DIRECTOR

Ulsan University Hospital

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

References

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Koo KI, Ko MH, Lee Y, Son HW, Lee S, Hwang CH. Comparison of a novel algorithm quantitatively estimating epifascial fibrosis in three-dimensional computed tomography images to other clinical lymphedema grading methods. PLoS One. 2019 Dec 10;14(12):e0224457. doi: 10.1371/journal.pone.0224457. eCollection 2019.

Reference Type DERIVED
PMID: 31821335 (View on PubMed)

Other Identifiers

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chhwang9

Identifier Type: -

Identifier Source: org_study_id

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